Magazine article FDA Consumer

FDA Moves toward Consistent Supplement Claims

Magazine article FDA Consumer

FDA Moves toward Consistent Supplement Claims

Article excerpt

Labeling claims about the health benefits of dietary supplements would be more reliable and uniform under an FDA proposal that establishes criteria for product label claims.

The proposed rule, published in the April 29, 1998, Federal Register, specifically defines two types of potential claims: "structure-function" claims, which describe how a product may affect the body's structure or functioning, and disease claims, which relate the product to its role in the treatment, diagnosis, cure, or prevention of disease. Under the 1994 Dietary Supplement Health and Education Act (DSHEA), structure-function claims are allowed, while disease claims are not.

FDA's proposal follows a report from the presidential Commission on Dietary Supplement Labels, an independent panel of experts charged under DSHEA with recommending measures for regulating dietary supplement claims. The proposal would not affect the availability of dietary supplements or consumers' access to them.

DSHEA allows manufacturers to use, without FDA authorization, structure-function claims that are truthful and not misleading. Under FDA's proposal, prohibited disease claims include those that imply or state that the product:

* has an effect on a specific disease or class of diseases. For example, the claim "protects against the development of cancer" would not be allowed, but the claim "helps promote urinary tract health" would be allowed as a structure-function claim.

* is in a drug class that is intended to be used to diagnose, mitigate, treat, cure, or prevent a disease. …

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